Systems and methods for varying elastic modulus appliances

ABSTRACT

The present invention provides improved devices, systems and methods for repositioning teeth from an initial tooth arrangement to a final tooth arrangement. Repositioning is accomplished with a system comprising a series of polymeric shell appliances configured to receive the teeth and incrementally reposition individual teeth in a series of successive steps. The individual appliances may be formed from layers having different stiffnesses (elastic moduluses), and the stiffnesses of successive appliances may be different, or both.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/139,796, filed Apr. 27, 2016, which is a continuation of U.S. patentapplication Ser. No. 14/298,030, filed Jun. 6, 2014, now U.S. Pat. No.9,351,809, issued May 31, 2016, which is a divisional of U.S. patentapplication Ser. No. 13/245,574, filed Sep. 26, 2011, now U.S. Pat. No.8,858,226, issued Oct. 14, 2014, which is a continuation of U.S. patentapplication Ser. No. 11/227,810, filed Sep. 14, 2005, now U.S. Pat. No.8,235,713, issued Aug. 7, 2012, which is a continuation of U.S. patentapplication Ser. No. 10/206,873, filed Jul. 26, 2002, now U.S. Pat. No.6,964,564, issued Nov. 15, 2005, which is a continuation of U.S. patentapplication Ser. No. 09/874,724, filed Jun. 4, 2001, now U.S. Pat. No.6,454,565, issued Sep. 24, 2002, which is a continuation-in-part of U.S.patent application Ser. No. 09/616,830, filed Jul. 14, 2000, now U.S.Pat. No. 6,524,101, issued Feb. 25, 2003, which claims the benefit ofU.S. Provisional Patent Application No. 60/199,650, filed Apr. 25, 2000,and U.S. Provisional Patent Application No. 60/199,649, filed Apr. 25,2000, the full disclosures of which are incorporated herein byreference. The disclosure of this application is also related to U.S.patent application Ser. No. 09/616,222, filed Jul. 14, 2000, now U.S.Pat. No. 6,572,372, issued Jun. 3, 2003, the full disclosure of which isincorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates in general to a method of repositioning teeth foruse in orthodontic treatment. Particularly, this invention relates tothe use of orthodontic appliances for producing tooth movements. Moreparticularly, this invention relates to the use of a plurality ofelastic repositioning appliances for producing such tooth movements.

Orthodontic treatments involve repositioning misaligned teeth andimproving bite configurations for improved cosmetic appearance anddental function. Repositioning teeth is accomplished by applyingcontrolled forces to the teeth over an extended period of time. This isconventionally accomplished by wearing what are commonly referred to as“braces.” Braces comprise a variety of appliances such as brackets,bands, archwires, ligatures, and O-rings. After they are bonded to theteeth, periodic meetings with the orthodontist are required to adjustthe braces. This involves installing different archwires havingdifferent force-inducing properties or by replacing or tighteningexisting ligatures. Between meetings, the patient may be required towear supplementary appliances, such as elastic bands or headgear, tosupply additional or extraoral forces.

Although conventional braces are effective, they are often a tedious andtime consuming process requiring many visits to the orthodontistsoffice. Moreover, from a patient's perspective, they are unsightly anduncomfortable. Consequently, alternative orthodontic treatments havedeveloped. A particularly promising approach relies on the use ofelastic positioning appliances for realigning teeth. Such appliancescomprise a thin shell of elastic material that generally conforms to apatient's teeth but is slightly out of alignment with the initial toothconfiguration. Placement of the elastic positioner over the teethapplies controlled forces in specific locations to gradually move theteeth into the new configuration. Repetition of this process withsuccessive appliances comprising new configurations eventually moves theteeth through a series of intermediate configurations to a final desiredconfiguration. A full description of an exemplary elastic polymericpositioning appliance is described in U.S. Pat. No. 5,975,893, and inpublished PCT application WO 98/58596 which designates the United Statesand which is assigned to the assignee of the present invention. Bothdocuments are incorporated by reference for all purposes.

In addition to their ease of use, polymeric positioning appliances aregenerally transparent, providing an improved cosmetic appearance, andimpart substantial force on the teeth, due to stiffness of theappliance. The stiffness of an elastic positioning appliance is a resultof the modulus of the thermoformable polymer materials from which it ismade. The higher the modulus of the materials, the higher the stiffnessof the appliance. When a patient positions such an appliance over aprescribed group of teeth, one or more of the teeth will provide a baseor anchor region for holding the positioning appliance in place whilethe stiffness of the polymeric material will impart a resilientrepositioning force against one or a portion of the remaining teeth.However, the stiffer the appliance, the more difficult it is to slip themisaligned appliance over the teeth and fully engage the appropriatesurfaces; the appliance often has the tendency to disengage or “popoff”. Likewise, once it is firmly seated, it is more difficult toremove. Further, a stiff appliance is less forgiving in cases of loweredpatient compliance. If a patient were to remove the appliance for anunprescribed period of treatment time, the patient's teeth may moveslightly out of the planned tooth arrangement. When attempting toreapply the appliance, it may be too rigid to accommodate these slightdifferences and a new appliance may need to be created. Similarly, thetooth positions defined by the cavities in each successive appliancemust not differ beyond a limiting dimension from those defined by theprior appliance or, again, it may be too rigid to accommodate thedifferences. Consequently, only small increments in tooth repositioningmay be made with each appliance.

Thus, it would be desirable to provide tooth positioners, systems, andmethods which apply adequate force to selected teeth yet overcome theinherent limitations of stiffness in the polymeric material. Likewise,it would be desirable to reduce the number of positioners required for atreatment plan by increasing the size of the repositioning incrementsthroughout the plan. Further, it would be desirable to reduce the costof lowered patient compliance by reducing the need for new appliances tobe created for patient treatment resumption. At least some of theseobjectives will be met by the designs and methods of the presentinvention described hereinafter.

SUMMARY OF THE INVENTION

The present invention provides improved devices, systems and methods forrepositioning teeth from an initial tooth arrangement to a final tootharrangement. Repositioning is accomplished with a system comprising aseries of polymeric appliances configured to receive the teeth in acavity and incrementally reposition individual teeth in a series ofsuccessive steps. This is accomplished by applying force to specificsurfaces of the teeth to cause directed movement. In order to apply suchforce, one or more of the teeth will provide a base or anchor region forholding the positioning appliance in place while the stiffness of thepolymeric material will impart a resilient repositioning force againstone or more of the remaining teeth. However, such stiffness createslimitations in ease of use, patient compliance, and overall cost inmaterial, manufacturing labor and treatment time.

To overcome these limitations, the present invention utilizes polymericor other material appliances with portions differing in rigidity,hardness, or stiffness. Portions of the appliance designed to applyspecific forces may have different elastic moduluses (stiffnesses)and/or hardnesses than other portions. Alternatively, elastic modulusesand/or hardnesses may vary from one appliance to the next in asuccessive series to accomplish various treatment goals. Thus, thesystems and methods of the present invention provide the design,production and use of such multiple stiffness positioning appliances inorthodontic treatment. Similarly, the devices of the present inventionprovide variable stiffness appliances which may be used independentlyfor purposes other than repositioning, such as for retaining teeth in adesired position. Thus, reference hereinafter to repositioningappliances with portions having differing or varying stiffnesses orhardnesses is not intended to limit the scope of the present inventionand is understood to include appliances of the described design forother purposes.

In a first aspect of the present invention, an elastic repositioningappliance may be comprised of portions with differing elastic moduluses.Elastic modulus may be used to express or describe the stiffness of amaterial or a material's resistance to elastic deformation. Therefore,elastic modulus may be used hereinafter to refer to stiffness. Thedifferent portions of the appliances will also usually vary in hardness.More usually, stiffer portions will be harder while the less stiffportions will be softer. Hardness is usually measured as a “durometer”reading on either the A or the D scale. In most instances, the presentinvention will be more concerned with the elastic modulus of thematerial since that will effect the force applied to the teeth foreither moving the teeth or for gripping or anchoring the teeth. In otherinstances, however, the hardness of the material may be more important,e.g., to avoid trauma to soft tissue regions engaged by the appliance.The remaining description and claims generally refer to materials havinggreater and lesser stiffnesses. It will be appreciated that suchterminology will also comprise materials having greater and lesserhardnesses.

The elastic modulus of a material is the ratio of the increment of unitstress to an increment of unit deformation within the elastic limit.When a material is deformed within the elastic limit, the bonds betweenadjacent atoms are stretched but not broken. The magnitude of theelastic modulus is indicative of the atomic and molecular bondingforces. When the stress is relieved, the material returns to itsoriginal shape and the deformation is nonpermanent. Different materialsmay have different elastic moduluses based on their molecularstructures. Some materials, such as certain polymers, may be speciallyproduced to have different elastic moduluses while retaining similarchemical compositions (and thus assuring compatibility of the differentmodulus materials in a single structure). Likewise, the elastic modulusof a polymer or other material may be enhanced or otherwise modified.This may be achieved by adding a powder, such as CaCO3, talc, TiO2,glass, diamond or a polymer powder, to name a few. In addition, this maybe achieved by embedding structural reinforcements, such as metalpieces, strips, wires, mesh, lattices, networks, polymeric filaments, orthe like. In addition, the elastic modulus may be altered bypost-production methods, such as layering, coating, interpenetrating,treating with various chemical agents, and altering the temperature, toname a few. In the resulting appliance, the elastic moduluses of thevarying portions will usually range from 0.5 to 5 GigaPascal (GPa),although in some instances portions of the appliance may fall outside ofthis range. The elastic modulus of one portion may differ from anotherportion by 25% to 600%, or more.

The differing elastic moduluses of different portions of the dentalappliance shells of the present invention will exist while the device ispresent over teeth in a normal oral environment. Thus, differentportions of the appliance shell will impart different forces to theimmediately underlying teeth, where the level of the force depends bothon the device geometry or tooth positions (relative to the underlyingtooth or teeth, which may vary over time) and on the elastic modulus ofthat portion of the device (which will remain constant over time in thenormal oral environment). The present invention should be distinguishedfrom that described in copending application Ser. No. 09/250,962, wherethe stiffness of a dental appliance shell may change over time by exposeto a non-oral environment, such as elevated temperature or changedosmolality. Of course, the dental appliance shells of the presentinvention which have different portions with differing stiffness mayalso incorporate regions (including the entire appliance) where a changein stiffness may be induced according to the teachings of applicationSer. No. 09/250,962, the full disclosure of which is incorporated hereinby reference.

In a first embodiment, portions of the shell of an elastic repositioningappliance may be composed of material(s) which differ in elasticmoduluses and/or hardnesses along a mesial-distal axis. A mesial-distalaxis may be defined as an axis following the gingival line or dentalarch. Thus, the elastic repositioning appliance may be comprised ofportions with a lower elastic modulus covering the molars, for example,and portions with a higher elastic modulus covering the remainder of theteeth. In this example, the portions may be relatively large so that aportion may receive one or more teeth, such as contiguous molars. Thismay be utilized when one or more teeth are to provide an anchor or baseregion for imparting repositioning force against another tooth or teeth.The portion of the appliance covering the anchor teeth may be of arelatively flexible nature with a lower elastic modulus than the portioncovering the teeth to be repositioned. This is because the portionscovering the anchor teeth may not need to apply repositioning forces tothe teeth they cover; they may merely be designed to hold the appliancein place. Consequently, a high level of rigidity or stiffness may not berequired. However, it may be appreciated that portions covering anchorteeth may in fact require a higher stiffness material than otherportions, including portions which are designed to apply repositioningforces. Thus, any variation of stiffness or elastic modulus along amesial-distal axis is included in this embodiment.

The introduction of such portions or regions with more flexibilityprovides utility in ease of use for the patient. The patient may findease in positioning the appliance with the more flexible portions firstwhich may guide the appliance in placement of the more rigid, slightlymisfit portions designed for repositioning. This sequence may bereversed in removal of the appliance. Likewise, such flexibility mayalso allow for any slight differences in mold versus appliance versusdentition geometry which may otherwise make placement and removal of theappliance more difficult. In some cases, a generally misfit appliancemay “pop off” or have a tendency to disengage even when properlypositioned over the teeth. Increased flexibility may reduce thesetendencies.

In further embodiments, portions of the elastic repositioning appliancemay vary in elastic moduluses along different and/or additional axes.For example, moduluses may vary along a facial-lingual axis. Facial maybe defined as next to or toward the lips or cheek, including termslabial and buccal. Lingual may be defined as next to or toward thetongue. Thus, a facial-lingual axis may be described as an axisfollowing a radial or similar line from the tongue toward the lips orcheek and vice versa. Likewise, moduluses may vary along agingival-crown axis. This may be described as a substantially verticalaxis following a line from the top of the crown at the edge of theocclusal surface of a tooth toward the gingival line or root and viceversa. In a preferred embodiment, an appliance may have a portion with alower elastic modulus covering the occlusal surfaces of the teeth and aportion with a higher elastic modulus covering the remaining surfaces ofthe teeth. Thus, the moduluses may vary along a facial-lingual axisand/or a gingival-crown axis, depending on the boundaries of thedelineated portions. Such a design may incorporate added flexibility tothe appliance while maintaining adequate repositioning forces in themost efficient areas.

In addition to varying in stiffness along the axes described above, theappliances of the present invention may vary in stiffness or hardnessover the “thickness” of the appliance. Usually, such variations andstiffness over the thickness will be accomplished by layering thedevice, i.e., with layers of differing stiffnesses or hardnesses beingplaced successively over the mold used to form the appliances, asdescribed in more detail below. Thus, the appliances may comprise shellshaving first and second portions, as generally described above, whereeach of those portions comprise layers in a laminar structure. Usually,at least one of the first and second portions will comprise a continuouslayer along the mesial-distal axis. The second and optionally additionallayers may also be continuous along the mesial-distal axis, but willoften be discontinuous, i.e., broken into two or more segments. Suchlayered devices can provide a variety of benefits. For example, layersformed from stiffer or harder materials can be used to more firmlyengage teeth, while the less stiff or softer layers can be used toprovide compliance and greater elasticity. In a particular preferredembodiment, the appliance comprises a discontinuous inner layer and acontinuous outer layer. At least a portion of the inner layer isconfigured to engage individual teeth or groups of teeth and will bestiffer or harder than the outer layer. The outer layer, which is lessstiff and therefore more compliant, provides the elasticity to move theteeth relative to one another, while the harder inner layer firmlyengages the teeth to provide a better grip or anchor upon the teeth.

It may be appreciated that the elastic modulus of the appliance shellsmay vary over any number of delineated portions. Such portions may be ofany size, shape, thickness, or dimension. Thus, such portions mayreceive entire teeth or they may be of the size to cover only a portionof a tooth or dental surface. When portions are relatively large, anappliance may be divided into, for example, two to five portions.Portions adjacent to one another differ in elastic moduluses, howevernot all portions of an appliance may differ from each other, such as inthe case of an appliance with portions alternating between twomoduluses. When portions are relatively small, an appliance may containan unlimited number of portions, varying along any axis or combinationof axes.

In a second aspect of the present invention, such appliances comprisedof portions having differing stiffness may be used independently or in aseries with similar or differing devices. When used independently, theappliance may be worn to achieve a specific goal with a single device.For example, the appliance may be used as a “retainer” to hold the teethin a desired position. Or, the appliance may be used for a specificone-time repositioning movement, such as “finishing” or correcting aslight misalignment. When used in a series, the appliances may comprisea system for repositioning teeth from an initial tooth arrangement to afinal tooth arrangement. In this case, a plurality of incrementalelastic position adjustment appliances comprising polymeric or othermaterial shells are successively worn by a patient to move teeth fromone arrangement to a successive arrangement. Individual appliances maybe configured so that their tooth-receiving cavity has a shape orgeometry corresponding to an intermediate or end tooth arrangementintended for that appliance. Thus, successive individual appliances mayhave a shape or geometry differing from that of the immediately priorappliance. According to the present invention, some or all of theindividual appliances may also be comprised of a material stiffnessdiffering from the stiffness of the immediately prior appliance. Inaddition, each individual appliance be comprised of portions withvarying stiffnesses. In some cases, of course, individual appliances inthe system may not vary in stiffness from prior or successiveappliances, but only in geometry. In other cases, individual appliancesmay vary only in stiffness (and not in geometry) when compared toimmediately prior or subsequent appliances. Thus, systems according tothe present invention may be comprised of appliances having stiffnessvarying within the appliance and/or from one appliance to the next inthe series.

In a specific embodiment, a system of elastic repositioning appliancesmay comprise individual appliances having uniform elastic moduluses overtheir entire tooth contact area where the moduluses will differ amongsuccessive appliances used in a course of treatment. The elastic modulusof a given appliance may be chosen to be most suitable for a specifictype of tooth movement, such as translating, tipping, root uprighting,rotation, extrusion, intrusion or a combination of these. For example,translation may require 70-120 gm of force, whereas rotation may onlyrequire 35-60 gm of force. Therefore, an elastic positioning appliancedesigned for translating teeth may need to have a higher elastic modulusthan one designed for purely rotating teeth. This is again due to thefact that stiffness of the appliance is a critical factor in impartingrepositioning force. Consequently, a series of appliances may beproduced for a treatment plan in which successive appliances designedfor a specific tooth movement may all have substantially similar elasticmoduluses. At the point in the treatment plan in which a different typeof tooth movement is desired, further appliances designed for the newtooth movement may have substantially similar elastic moduluses to eachother but different from the previous appliances. Such a sequence may berepeated at any time or may continue with new moduluses and toothmovements.

In an additional specific embodiment, one or more appliances may beproduced with a suitably flexible elastic modulus to receive andresiliently reposition teeth from an unprescribed arrangement to aprescribed arrangement. This might be necessary in cases of loweredpatient compliance. If a patient were to remove an appliance for anunintended and/or extended period of a prescribed treatment time, thepatient's teeth may move slightly out of the planned tooth progression.When attempting to reapply the appliance, an appliance which is toorigid may not be able to accommodate these slight differences. Thus, amore flexible appliance (but having an identical geometry) may beproduced for this purpose and may be incorporated into the treatmentplan at any given point in the series of successive appliances. Theability to return to the same geometry is an advantage because itminimizes the need to replan the treatment protocol.

In a third aspect of the present invention, systems for repositioningteeth from an initial tooth arrangement to a successive tootharrangement comprise a plurality of incremental elastic positionadjustment appliances in which at least one appliance has the same shapeyet different elastic modulus as an immediately prior appliance. In aspecific embodiment, a series of incremental appliances may be producedwith differing elastic moduluses to reposition teeth from an initialtooth arrangement to the next successive tooth arrangement in aprogression of arrangements to the final arrangement. Each of theappliances in the series from the first to the next successive tootharrangement may have the same shape or geometry since the tooth movementrepresents one step in tooth movement. However, the variance in elasticmoduluses may allow for a larger step or increment in tooth movementthan may be obtainable with consistent, rigid appliances. For example,an appliance may be produced with a tooth arrangement which issubstantially misaligned from the initial arrangement. High modulusappliances may not be flexible enough to allow the appliance to fit overthe teeth in the initial arrangement. However, a series of appliances ofthe same shape may be produced with increasing elastic moduluses fromrelatively low to adequately high. The patient may begin with the lowestelastic modulus appliance which may be the most flexible to fit over theteeth. As the teeth are repositioned, the patient may successivelyutilize each appliance in increasing modulus until the teeth haveconformed to the successive tooth arrangement. At that time, the patientmay begin a new series of appliances with varying moduluses and a shapeto reposition the teeth to the arrangement of the next step in therepositioning progression. The ability to reduce the number of differentappliance geometries required for a single course of treatment canprovide a significant reduction in planning effort and manufacturingcosts.

In a fourth aspect of the present invention, the elastic modulus of anappliance or portions of an appliance may be modified in a number ofdifferent ways. To begin with, the elastic modulus may be determined bythe choice of materials. For example, metals will generally have ahigher elastic modulus than polymers due to atomic structure. Forexample, the modulus values for metals may range between 48 and 414 GPa,whereas the modulus for polymers may range from 0.5 to 35 GPa. Thus, itwill be possible to form appliances having moduluses which differgreatly by forming different portions from metal(s) and polymer(s), orby forming successive appliances from metals and polymers. Usually,however, the appliances will comprise or consist of a polymeric shellformed from a single polymer, multiple polymers, copolymers, and thelike, typically by thermoforming and/or lamination. Stiffness of apolymer may be varied within a range (typically 0.5 GPa to 5 GPa) bychanging the molecular structure of the polymer chains. Polymer chainswith hindered side-chains are unable to pack as closely as those withsmaller side-chains. Thus, such a polymer may have more intermolecularmotion and therefore a lower bulk elastic modulus. Stiffness can also bechanged by controlling the degree of cross-linking as well as thecross-linking entity within a polymer or copolymer. Further,alternatively, differing elastic moduluses may be created within thesame polymer shell by layering or laminating the same or differentpolymers. Two layers of a polymer material bonded together to form anintegral appliance, i.e., an appliance having a monolithic shellstructure where the layers are resistant to delamination, may have ahigher elastic modulus than a single layer of such material. Thirdly,different elastic moduluses may be created with a single layer of onetype of polymer material by production methods, such as coating,treating with various chemical agents, and altering the temperature, toname a few.

Further, different elastic moduluses may be produced by formingselectively reinforced and/or composite-type materials. For example, apolymer material may be reinforced with structures such as strips,wires, pieces, mesh, lattices, networks, and the like. These structuresmay be comprised of any suitable material, particularly metals andalloys but also including polymer filaments, wires, braids, and thelike. Likewise, composite materials may be comprised of interpenetratingpolymeric networks. An interpenetrating polymeric network is comprisedof a base material and an additional material that interpenetrates thebase material to alter its mechanical properties. For example, the basematerial (A) may be a solid polycarbonate. The added material (B) may bea liquid polymer, monomer or crosslinking agent which is allowed tointerpenetrate and activate to form a composite network. The composite(A+B) may have a stiffness which is greater than the sum of its parts,(A) and (B). Further, another material (C) may also be allowed tointerpenetrate and activate to form a new composite network. Thecomposite (A+B+C) may also have a stiffness which is greater than thesum of its parts, (A), (B) and (C). With this method, any number ofcomposites may be formed providing a wide range of mechanicalproperties, specifically stiffnesses. In addition, a number of theseproduction methods may provide materials with gradual changes in elasticmoduluses. For example, purposely irregular coating of a polymermaterial may provide higher stiffness in areas with thicker coating andlower stiffness in areas with thinner coating. This may be applied to anumber of production methods.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective illustration of an embodiment of an appliance ofthe present invention and descriptive axes.

FIG. 2 illustrates an embodiment of an appliance with relatively largeportions varying in elastic modulus along a mesial-distal axis.

FIG. 3 illustrates an embodiment of an appliance with smaller portionsvarying in elastic modulus in a non-symmetric pattern along amesial-distal axis.

FIG. 4 illustrates an embodiment of an appliance varying in elasticmodulus along a mesial-distal axis in which portions covering proximalor interproximal spaces are of differing modulus.

FIG. 5 illustrates a variety of appliance portions varying in elasticmodulus along a mesial-distal axis.

FIG. 6 is a perspective illustration of an embodiment of an appliancevarying in elastic modulus along a facial-lingual axis.

FIG. 7 illustrates a variety of appliance portions varying in elasticmodulus along a facial-lingual axis.

FIG. 8 is a perspective illustration of an embodiment of an appliancevarying in elastic modulus along a gingival-crown axis.

FIG. 9 illustrates a variety of appliance portions varying in elasticmodulus along a gingival-crown axis.

FIG. 10 illustrates a variety of appliance portions varying in elasticmodulus along one or more described axes.

FIG. 11 depicts a series of appliances differing in elastic modulus atspecific intervals throughout a treatment plan.

FIG. 12 illustrates the use of an “off track” appliance in a prescribedtreatment plan.

FIG. 13 illustrates the use of a series of appliances with graduallyincreasing elastic moduluses and similar or identical geometry in aseries of intervals throughout a treatment plan.

FIG. 14 illustrates a method of fabricating a multi-modulus appliance.

FIG. 15 illustrates a method of layering to fabricate a multi-modulusappliance.

FIG. 16 illustrates an additional method of layering to fabricate amulti-modulus appliance.

FIG. 17 illustrates an exemplary layered appliance according to thepresent invention with portions broken away.

FIG. 18 is a cross-sectional view taken along line 18-18 of FIG. 17.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides improved devices, systems and methods forincrementally repositioning teeth using a plurality of discretepolymeric appliances of variable flexibility, where each appliancesuccessively repositions one or more of the patient's teeth byrelatively small amounts. Flexibility may be defined by elastic modulusof the polymeric material and may vary within a given appliance or mayvary throughout a series of appliances according to a prescribedorthodontic treatment plan.

Referring to FIG. 1, portions of an elastic repositioning appliance 100may vary in elastic modulus along a mesial-distal axis 101,facial-lingual axis 102, gingival-crown axis 103, or any axis in-betweenthese representative axes. As previously described, a mesial-distal axismay be described as an axis following the gingival line or dental arch,a facial-lingual axis may be described as an axis following a radial orsimilar line from the tongue area toward the lip or cheek area, and agingival-crown axis may be described as an axis following asubstantially vertical line from the crown of a tooth toward thegingival line or root. Such axes are defined for descriptive purposesand are not intended to limit the scope of the present invention.

As shown in FIG. 2, portions of an elastic repositioning appliance 100may vary in elastic modulus mesial-distally. For illustrative purposes,portions with a lower elastic modulus 110 are shaded to easilydistinguish differences in elastic modulus throughout a device. In thisexample, the appliance 100 may be described as having three portions.Two portions cover contiguous sets of molars and are comprised of anelastomeric material of a lower elastic modulus 110 and are thus shaded.The portion in-between these portions is of a higher elastic modulus 111and is thus not shaded. All portions in this embodiment are relativelylarge so that the portions may receive one or more teeth, such asmolars, premolars, incisors, and the like. Likewise, nonadjacentportions may have the same elastic modulus, such as the two lowerelastic modulus 110 portions, or they may be different from each otherwhile maintaining a difference from the higher elastic modulus 111portion. In other words, an appliance 100 with three distinct portionsmay be comprised of two or three elastic moduluses.

As illustrated in FIG. 3, such portions may not be symmetrical and theymay not cover more than one tooth. Portions with a lower elastic modulus110 may alternate in an uneven fashion along a mesial-distal axis asshown. In addition, adjacent portions may be of a size to cover only aportion of a tooth or dental surface. Referring to FIG. 4, portions oflower elastic modulus 110 may be present covering the facial or lingualsurfaces of the teeth, while portions of higher elastic modulus 111 maybe present covering the proximal or interproximal spaces. This may beadvantageous to provide repositioning forces, such as translationforces, at the most efficient locations for this type of movement. Atthe same time, flexibility is provided in portions that may be lessinvolved in the application of force, allowing more freedom and comfortfor the patient.

Referring to FIG. 5, the elastic modulus of an appliance 100 may varyover any number of delineated portions and may be of any size, shape,thickness or dimension, to name a few. Such portions may be sized toreceive an entire tooth 115 or they may be of the size to cover only aportion of a tooth. For example, a portion with a lower elastic modulus110 may be sized to cover a proximal or interproximal space 116,including portions covering the gingival line. This may be desirable toprovide comfort to the gums when wearing the appliance, and also toincrease the contact of the appliance with the interproximal regions. Inthis case, softer, more flexible material may be able to form moreclosely to the interproximal regions, enabling a higher level ofrepositioning force to be applied.

Portions may also be sized and arranged to cover part of a facialsurface 117, or two or more of such portions may cover part of a facialsurface 118, allowing the elastic modulus to vary mesial-distally withina single tooth. Further, the portion may be sized to cover an isolatedregion of a facial surface 119. Such embodiments are a limitedpresentation of the possible sizes, configurations, and combinations ofvarying elastic modulus portions in an appliance 100 of the presentinvention. Such possibilities may be unlimited.

As shown in FIG. 6, portions of an elastic repositioning appliance 100may vary in elastic modulus facial-lingually. In this embodiment, theappliance 100 is shown to have a portion with a lower elastic modulus110 covering a portion of the occlusal surfaces of the teeth and aportion with a higher elastic modulus 111 covering the remainingsurfaces of the teeth. Thus, the elastic modulus varies along afacial-lingual axis. Such a design may be beneficial to providerepositioning forces, such as translation forces, along the proximaland/or interproximal spaces which are the most efficient locations forthis type of movement. At the same time, flexibility is provided inportions that may be less involved in the application of force, theocclusal surfaces. This may allow increased freedom and comfort for thepatient while maintaining adequate repositioning forces.

Referring to FIG. 7, the elastic modulus of an appliance 100 may againvary over any number of delineated portions and may be of any size,shape, thickness or dimension, to name a few. A portion of lower elasticmodulus 110 may be sized to cover only a portion of a tooth. Forexample, it may cover the center of the occlusal surface 125,alternating cusps or cusp tips 126, or isolated portions of any givencusp or cusp tip 127. Likewise, a portion of lower elastic modulus 110may be of a larger size to cover, for example, the outside margin orbuccal cusps of a tooth 128 or the inside margin or lingual cusps of acontiguous grouping of teeth 129. As before, such embodiments are alimited presentation of the possible sizes, configurations, andcombinations of varying elastic modulus portions in an appliance 100 ofthe present invention. Such possibilities may be unlimited.

As shown in FIG. 8, portions of an elastic repositioning appliance 100may vary in elastic modulus crown-gingivally. In this embodiment, theappliance 100 is shown to have a portion with a lower elastic modulus110 covering the occlusal surfaces of the teeth and a portion with ahigher elastic modulus 111 covering the remaining surfaces of the teeth.This is a modified representation of the embodiment depicted in FIG. 6in which the portion of lower elastic modulus 110 partially covered aportion of the occlusal surfaces. In this embodiment, the occlusalsurface is substantially covered with the lower elastic modulus 110material, therefore it may be considered to be uniform, non-variable,along a facial-lingual axis. It may be more properly described asvarying along a gingival-crown axis, as the lower elastic modulus 110portion may extend over the cusps of the tooth crowns. Thus, the lowerelastic modulus 110 material may be seen as being located at the tip ofthe crown region and vary to a higher elastic modulus 111 materialtoward the gingival line or margin. In addition, a higher elasticmodulus 111 material along the gingival line or margin may improveretention of the device on the teeth. This may also reduce the need forattachment devices to aid in retention. A full description of exemplaryattachment devices and methods for a dental appliance is described inco-pending application Ser. No. 09/454,278, incorporated by referencefor all purposes and assigned to the assignee of the present inventor.However, such modulus differences are presented only for descriptivepurposes and such portions may vary over one or many axes simultaneouslyor in isolated regions of an appliance 100.

It may be appreciated that the advantages offered by a lower elasticmodulus along the occlusional surfaces, as depicted in FIG. 6 and FIG.8, may be further increased by removing the material from the shell inthese areas. Removal of material may form a window such that when theshell is positioned over the patient's teeth, portions of the teethbeneath the window may be exposed. In a preferred embodiment, apolymeric shell may have a plurality of windows over portions of theocclusal surfaces of the teeth. In this case, segments of the shell maystill be present along the facial and lingual surfaces of the teeth andacross the interdental regions or spaces between the teeth. Exposure ofthe occlusal surfaces in appropriate size and location may allowinterdigitation of the upper and lower teeth. This may also be achievedwith the presence of one or a few larger windows over portions of theocclusal surfaces of the teeth. In these cases, segments of the shellmay not be present across the interdental regions or spaces between theteeth. In either case, interdigitation of at least portions of the upperand lower teeth may benefit tooth and jaw orientations, leading toimproved treatment, appearance, comfort and consequently patientcompliance. Thus, such windows may provide the benefits offered by alower elastic modulus, such that the lowest stiffness may be provided bythe absence of the material, while providing additional benefitsdescribed above. A full description is provided in U.S. patentapplication Ser. No. 09/616,222, assigned to the assignee of the presentinvention.

Referring to FIG. 9, the elastic modulus of an appliance 100 may againvary over any number of delineated portions and may be of any size,shape, thickness or dimension, to name a few. A portion of lower elasticmodulus 110 may be sized to cover only a portion of a tooth along thisaxis. For example, it may cover the upper portion of the lingualsurfaces near the cusps of the crown 135, or a midway “stripe” throughthe lingual surface of a tooth 136. Likewise, it may be sized so thatmore than one “stripe” may cover the surface of a tooth 137, as in thecase of a portion at the gingival margin and a portion near the cusps ofthe crown. Similarly, a portion of lower modulus may be sized so that itcovers a contiguous grouping of teeth, such as the buccal surfaces alongthe gingival margin 138. As before, such embodiments are a limitedpresentation of the possible sizes, configurations, and combinations ofvarying elastic modulus portions in an appliance 100 of the presentinvention. Such possibilities may be unlimited.

As illustrated in FIG. 10, variance in elastic modulus in relation tosize, shape, location, orientation, and axis, as described above, may becombined in a single appliance 100 to provide an unlimited variety ofappliance 100 designs and constructions. In this example, portions ofthe appliance 100 vary mesial-distally, such as by comparing the lowerelastic modulus 110 portion covering a group of incisors with the higherelastic modulus 111 portion covering the canine tooth. Portions may alsovary facial-lingually, as depicted by the partial covering of theocclusal surfaces of the molars 150 or the isolated portion of a givencusp or cusp tip 127. Likewise, portions may vary crown-gingivally, suchas the portions covering the buccal surfaces along the gingival margin138. These portions also vary mesial-distally creating a compoundvariance, as portions adjacent to these areas are not identical, as incomparison of portions covering the buccal surfaces along the gingivalmargin 138 with the adjacent tooth 151 having partial covering of theocclusal surface of the molar 150. Portions may also vary along thethree major axes simultaneously. This can be seen in the portioncovering the center of an occlusal surface 125, which variesfacial-lingually, the lingual face of a molar along the gingival margin152, which varies crown-gingivally, and the adjacent uniformly coveredmolar 153, which varies mesial-distally in relation to the previousportions.

According to the present invention, systems for repositioning teeth froman initial tooth arrangement to a final tooth arrangement may becomprised of a plurality of incremental elastic position adjustmentappliances with varying elastic moduluses. Thus, in addition to combinedvariances in a given appliance 100, as described above, a plurality ofsuch appliances 100 with differing patterns of elastic modulus variancemay be used in a system for repositioning teeth throughout a sequence oftooth arrangements. This may be illustrated by FIGS. 2-10 with differingtooth geometries, viewed as a series of appliances 100 for a singletreatment plan.

Alternatively, as shown in FIG. 11, the polymeric shells of theappliances 100 may have uniform elastic moduluses over their entiretooth contact area. In this depiction, each appliance 100 differs inshape or tooth geometry and represents a stage in the overall treatmentplan. Thus, five stages are depicted, as there are five appliances 100shown. The first three appliances 200, 201, and 202, respectively, mayhave a uniform elastic modulus chosen for a specific type of toothmovement. For example, appliances 200, 201 and 202 may be designed forpure translation, requiring a relatively high elastic modulus 111. Thus,the appliances are not shaded in the illustration. At stage 4, adifferent type of tooth movement, such as tipping, may be desiredrequiring a lower elastic modulus 110. Therefore, appliances 203 and 204may continue the series of differing shape or tooth geometries to createsuch movements, but the elastic modulus may differ from the priorappliances, 200, 201, and 202. Thus, these appliances are shaded in theillustration. The remainder of the treatment plan may feature a similarseries of appliances, including appliances with uniform elasticmoduluses which differ from the appliances immediately prior and/or anyappliances previously presented in the series. Likewise, such a seriesmay also include appliances with combined variances, as described above.

Similarly, as shown in FIG. 12, a treatment plan may be prescribed witha series of appliances 100 differing in shape or tooth geometry, ofwhich four stages are depicted, 210, 211, 212 and 213. Such appliancesmay have any given elastic modulus that is suitable for the prescribedfunction. Likewise, such appliances may have internal variance inelastic modulus, described previously, or may vary wholly from applianceto appliance throughout the prescribed treatment plan. However, if apatient were to discontinue usage of an appliance for an unprescribedperiod of treatment time, such as between stages two (appliance 211) andthree (appliance 212) depicted in FIG. 12, the patient's teeth may moveslightly out of the planned tooth arrangement. Such a patient may beconsidered “off track” in which their current tooth arrangement hasdiverted from the series of projected tooth arrangements, creating anunprescribed tooth arrangement. When attempting to apply the nextsuccessive appliance 212, it may be too rigid to accommodate theseslight differences. Therefore, a new more flexible appliance 214 may beproduced for this purpose and may be incorporated into the treatmentplan. Such an appliance 214 may have the same shape or tooth geometry asthe next successive appliance 212, but it may have a lower elasticmodulus 110, depicted by shading. The increased flexibility may allowthe appliance 214 to conform to the unprescribed arrangement andreposition the teeth toward an arrangement that the next successiveappliance 212 may therefore fit. Such an appliance 214 may be used atany point in the series of successive appliances.

As shown in FIG. 13, a series of incremental appliances, 300, 301, 302,303, 304 and 305, may be produced with differing elastic moduluses,illustrated by variation in shading, to reposition teeth from an initialtooth arrangement to the next successive tooth arrangement in aprogression of arrangements to the final arrangement. FIG. 13illustrates two steps in such a progression. A step or stage representsa change in shape or geometry of an appliance 100 to reposition theteeth into the next prescribed arrangement in a series. Therefore,appliances 300, 301, and 302 represent the first stage and have oneshape and 303, 304, and 305 represent the second stage and have adiffering shape. The appliances 300, 301, and 302 representing the firststage may vary in elastic moduluses from more flexible (appliance 300)to more rigid (appliance 302). The patient may begin the treatmentsequence with the more flexible appliance 300 of the first stage. Suchflexibility may allow an appliance with a substantially misalignedgeometry to fit over the patient's teeth and apply repositioning forces.As the teeth gradually move toward the desired arrangement, the patientmay progress to the next appliance 301 in the first stage. Thisappliance 301 may be more rigid than the prior appliance 300. Thepatient may continue through any number of appliances throughout astage. Upon completion of the stage, the patient may repeat the processin stage two, beginning with the more flexible appliance 303 andculminating with the more rigid appliance 305. The patient may thencontinue through any number of stages to the endpoint of treatment.

Such a system may provide a number of benefits. First, the variance inelastic modulus throughout each step may allow for a larger step orincrement in tooth movement between each step than may be obtainablewith consistent, rigid appliances. Such flexibility may allow theappliance to fit over a tooth arrangement that is more misaligned whilethe increase in rigidity throughout each stage may provide sufficientrepositioning forces which may not be obtainable with highly flexibleappliances. These larger steps require fewer appliances in a series tohave a change in shape or geometry. Consequently, fewer molds may berequired to form such appliances, which lowers cost and treatment timefor the patient. In addition, if the patient were to become “off track”by suspending treatment, it may be possible for the patient to resumethe prescribed treatment plan by reentering treatment at the start ofthe step or stage in which the patient previously aborted. Thisappliance may be flexible enough to fit over the teeth in theunprescribed arrangement and gradually reposition the teeth throughoutthe stage as originally prescribed. This may also reduce cost andtreatment time since the production and fitting of a flexible “offtrack” appliance, as illustrated in FIG. 12, may be avoided.

The elastic modulus of an appliance or portions of an appliance of thepresent invention may be determined by a number of design features,methods, materials and similar means. In a preferred embodiment, theappliance may be comprised of a polymeric shell which is heat formedover a mold of a patient's dentition. This is typically accomplished byheating a thermoformable polymer material and applying vacuum orpressure to form the polymer to the mold. Alternatively, reactioncasting may be used to produce such an appliance. Hereinafter,description will pertain to thermoforming, however such concepts andtechniques may be equally applied to reaction casting or similar methodsand are not to limit the scope of the invention.

To produce an appliance with uniform elastic modulus, a polymer sheetwith a specific elastic modulus and thickness may be thermoformed over amold and trimmed for patient use. Appliances with differing uniformelastic moduluses may be produced by altering one or more of threevariables: 1) polymer type, 2) elastic modulus, 3) thickness. To producean appliance with portions of differing elastic moduluses, a number oftechniques may be utilized. Referring to FIG. 14, portions of polymersheeting 400 may be positioned over a mold 401 in designated areas andthermoformed together into a final polymeric appliance. Each portion ofsheeting 400 may be chosen based on the three above mentioned variablesto provide a desired elastic modulus. Each portion of sheeting 400 maythen be positioned in the desired location for elastic modulus changesthroughout the finished appliance. In FIG. 14, three portions arepresented, a first sheet 402 placed over the right side molars, a secondsheet 403 placed over the left side molars and a third sheet 404 placedover the remainder of the teeth. Sheets 402 and 403 are depicted ashaving differing elastic moduluses to each other and to sheet 404, asshown by shading gradations, however such sheets 402, 403, may beidentical. After thermoforming, a finished appliance may appear as thatillustrated in FIG. 2.

In addition, portions with differing elastic moduluses may be createdwith the same polymer or different polymers material by layering. Twolayers of a polymer material bonded together may have a higher orelastic modulus than a single layer of such material. As illustrated inFIG. 15, a first sheet 405 may be placed over the incisors, canines andpremolars of the mold 401 and a second sheet 406 may be placed over theentire dentition. Each sheet may be the same or may differ in terms ofany or all of the above mentioned variables. After thermoforming, afinished appliance may also appear as that illustrated in FIG. 2. Inthis case, the shell covering the molars is comprised of one layer andthe remainder of the appliance is comprised of two layers formed into anintegral appliance structure. Therefore, the portions covering themolars may have a lower elastic modulus, depending on the combination ofmaterials, than the remaining portion. However, it is possible that amulti-layered structure may have a lower elastic modulus than a singlelayered structure depending on the above mentioned variables. Thus, itmay be appreciated that the described layering technique may provide avariety of moduluses and those stated examples are not intended to limitthe scope of the invention.

Similarly, portions with different elastic moduluses may be created by amulti-step process of layering. Referring to FIG. 16, a first sheet maybe thermoformed over the entire dentition of a mold 401 to form a baseappliance 410. Portions desired to be of a differing elastic modulus411, demarcated by a dashed line, may be cut and removed from the formedbase appliance 410. A second sheet 412 may then be thermoformed over theentire dentition. This may result in a single layer of material in theportion of differing elastic modulus 411 and a double layer of materialin the remaining areas.

It may be appreciated that appliances with differing and graduallychanging elastic moduluses may be created by any number of productionmethods. For example, a base appliance 410 may be coated in a specificarea with one or more polymer solutions to “build up” a portion of theappliance for localized rigidity. Such a build-up may also be gradualfor a more gradual increase in rigidity. Likewise, a base appliance 410may be treated in specific areas with various chemical agents to eitherincrease or reduce localized rigidity. This may also include treatmentsinvolving temperature changes and other phase altering methods.Similarly, such methods may be combined, including any or all of theabove described methods. Likewise, such methods may be utilized forappliances of uniform elastic modulus.

The fabrication process illustrated in FIG. 16 may be used to prepare apreferred laminated appliance structure 500, as illustrated in FIGS. 17and 18. An inner layer 502 is formed from a relatively stiff polymericmaterial and molded over a positive tooth model which represents thedesired appliance geometry. After the layer 502 is formed, it can besegmented into two or more sections which conform to individual teeth orgroups of teeth when the appliance is placed over the patient's jaw. Asshown in FIG. 17, gaps 504 may be formed between individual sections506, each of which conform to and receive an individual tooth or groupof teeth. An outer layer 508 is continuous in the mesial-distal axis andcovers all the segments 506 of the inner layer 502. By providing aninner layer 502 having a higher stiffness, firm gripping or anchoring ofthe underlying teeth can be achieved. Moreover, by providing an outerlayer 508 which is less stiff or more compliant, ease of removing andreplacing the appliance can be significantly improved. Moreover, thestiffness or anchoring force can be enhanced without having toconcurrently modify the overall or effective elasticity of the appliancewhich can be selected based on the clinical requirements of movingteeth. That is, the elasticity of the outer layer can be selected toprovide an appropriate tooth movement force while that of the innerlayer can be chosen to enhance seating characteristics over the teeth.In a specific embodiment, the compliance of the outer layer 508 could bevaried along the mesial-distal axis in order to provide for differingforces on the teeth, as discussed generally above.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that various alternatives,modifications and equivalents may be used and the above descriptionshould not be taken as limiting in scope of the invention which isdefined by the appended claims.

1. (canceled)
 2. A dental appliance comprising: a polymeric shell havingcavities shaped to engage individual teeth, the polymeric shellcomprising: a first layer being a discontinuous inner layer; adiscontinuity in the first layer; and a second layer being a continuousouter layer and being formed over the first layer; wherein the one ormore discontinuities of the first layer comprise a first window formedthrough said first layer.
 3. An appliance as in claim 2, wherein thefirst layer has a first elastic modulus and the second layer has asecond elastic modulus, the first and second elastic moduli being in therange from 0.5 to 5 GPa.
 4. An appliance as in claim 2, wherein thefirst elastic modulus differs from the second elastic modulus by 25% to600%.
 5. An appliance as in claim 2, wherein the first window is formedthrough the first layer vary along one or more of a mesial-distal axis,facial-lingual axis, and gingival-crown axis.
 6. An appliance as inclaim 2, wherein the first window is formed through the first layer on abuccal wall of a cavity.
 7. An appliance as in claim 2, wherein thefirst window is formed through the first layer on a lingual wall of acavity.
 8. An appliance as in claim 2, wherein the first window isformed through the first layer on an occlusal surface of a cavity.
 9. Anappliance as in claim 2, wherein at least a region of the shellcomprises a material reinforced with a structure comprising one or moreof strips, wires, mesh, lattices, and networks.
 10. An appliance as inclaim 9, wherein the structure comprises a polymer.
 11. An appliance asin claim 9, wherein the structure comprises a metal or alloy.
 12. Anappliance as in claim 2, wherein at least a region of the polymericshell comprises a metal or alloy.
 13. A method for producing a dentalappliance, the method comprising: providing a mold of the patient'sdentition; forming a first material layer over the mold; forming awindow though the first layer; and forming a second material layer overthe first material layer so as to produce the dental appliance.
 14. Themethod of claim 13, wherein an appliance with a uniform elastic modulusis produced.
 15. The method of claim 13, wherein an appliance with oneor more portions of differing elastic moduli are produced.
 16. Themethod of claim 13, wherein removing one or more portions of the firstmaterial layer forms one or more discontinuities.
 17. The method ofclaim 16, wherein the one or more discontinuities through the firstlayer comprise windows.
 18. A orthodontic system comprising: a pluralityof dental appliances configured to move at least one tooth between afirst position and a second position, each dental appliance comprising:a polymeric shell having cavities shaped to engage individual teeth, thepolymeric shell comprising: a first layer being a discontinuous innerlayer; a discontinuity in the first layer; and a second layer being acontinuous outer layer and being formed over the first layer; whereinthe one or more discontinuities of the first layer comprise a firstwindow formed through said first layer.
 19. An appliance as in claim 18,wherein the first window is formed through the first layer vary alongone or more of a mesial-distal axis, facial-lingual axis, andgingival-crown axis.
 20. An appliance as in claim 18, wherein the firstwindow is formed through the first layer on a buccal wall of a cavity.21. An appliance as in claim 18, wherein the first window is formedthrough the first layer on a lingual wall of a cavity.